The race is on for the most effective and safest anti-obesity drug. Abbott, the makers of Meridia (Sibutramine) and Arena, the makers of Locaserin, are going head to head in September at the FDA in the US. Abbot will present to an advisory panel of the US Food and Drug Administration who will be reviewing on-going post-authorization clinical studies into the controversial drug Sibutramine on September 15th. The following day, the same panel will review the clinical data on new drug candidate, Lorcaserin.

Sibutramine, also known as Reductil, was only taken from the shelves in January after the European Medicines Agency (EMA) recommended its suspension after a 6 year study which revealed that patients taking Sibutramine showed an increase in the risk of non-fatal cardio vascular events where there was a pre-existing cardiovascular problem. The problem with this study was that it concentrated on a population group actually contraindicated for sibutramine under the terms of its marketing authorisation, leading many experts to criticise the decision of the EMA. Abbott is confronting the regulators again and is hoping to generate a different sort of recommendation.

The Endocrinologic and Metabolic Drugs Advisory Committee will review Lorcaserin just one day after Abbott’s meeting with the FDA. It is anticipated that the result for Loracserin will be positive given that it appears to meet the benchmark criteria in terms of weight loss and the side effects appear to be minor. Also, unlike Qnexa, which got the thumbs down last month, Lorcaserin has been studied over two years. Lorcaserin, in its phase III of clinical testing, triumphed when 7% of both the Lorcaserin users and the placebo users stopped taking the treatment due to the experiencing of uncomfortable side effects.  Lorcaserin has the lowest discontinuation rates of any anti-obesity treatment.

Whilst we desperately need new treatments to help with the burgeoning problem of obesity, we need to make sure that the risks associated with taking any new drug do not outweigh the benefits.

An exciting time for Denmark based drug company 7TM Pharma, as they complete the first stage of clinical trials for the as yet unnamed drug molecule, TM38837. Likened to effective weight loss drugs of the past such as Acomplia, the drug will perform similarly but without the side effects once associated with other drugs from the same family.

TM38837 functions as a CB1 receptor blocker. This drug blocks the cannabinoid receptors which are responsible for the feeling of hunger. Such antagonists work directly on the central nervous system and in the past have been criticised for their harmful, psychological effects. Although blocking the same receptors as Acomplia once did, TM38837 does so without crossing the blood-brain barrier to any significant degree and instead concentrates on blocking receptors in the peripheral nervous system. This action is likely to eliminate the psychiatric side effects associated with Acomplia.

Rigorous clinical trials are being carried out and so far the results have been successful and out of 48 healthy adults tested, only 7 experienced mild side effects with a majority responding well. It will be this Autumn before the results of the next stage of clinical trials are available. If the trials are successful, this will finally be a major advancement for weight loss drugs.

The Food and Drug Administration in the US has removed the dietary food supplement, ‘Joyful Slim’ from the shelves following evidence that it contains the drug Sibutramine.

Rather surprisingly, an FDA panel has voted against approval of the proposed weight –loss drug Qnexa.

The vote, taken yesterday, was narrowly lost by 9 to 7. The panel said that though they believed that Qnexa was effective, they were worried about granting approval before several key safety concerns are resolved.

The panel agreed that the new medication does work better than any currently approved weight loss drug, enabling users to lose up to 14.7% of their body weight when used in conjunction with a diet and exercise program.

However they were concerned that the medication could potentially cause a series of side effects, including birth defects, an increased suicide risk and an increased risk of kidney stones.

Qnexa uses two medications which are already on the market, phentermine and the seizure drug topimirate. While both medications are approved separately, it seems that the panel were disturbed by how many people were projected to want to try the medication. Millions in America are obese and a large number of those are likely to want to try a new slimming pill, were it to be available.

The panel said that as the clinical trials lasted for only a year, it was ‘impossible to extrapolate the trial data to the wider population’, according to panel chair Kenneth Burman of Georgetown University.

While the FDA does usually follow the advice of their panel when deciding whether or not to grant approval for a new medication, they are not obliged to do so. The closeness of the vote made FDA Deputy Director of Endocrine Products, Eric Coleman, say in a news conference that there was a sense that a lot of people were hesitant over whether or not to give the drug the go-ahead.

Well, we seem to have missed something for a change. Apparently a new slimming pill was launched over the counter a couple of weeks ago and it sold out within 3 days – all 50,000 packs flew off the shelves.

The “new” treatment is called Capsiplex and it contains the active ingredient Methylcellulose. Methylcellulose has been available for a number of years and it is used to treat diarrhoea and constipation. You might think that it is a bit weird that the same medication is used to treat two diametrically opposed conditions but it will have different effects based on the amount of water that you drink. Methylcellulose has also been prescribed to treat obesity by acting as an appetite suppressant. We are not entirely sure how effective this has been but we are looking into offering this to patients of The Online Clinic. If we can get some reliable clinical data that would give us confidence that the treatment works then we will seriously consider offering as a treatment option.

At the current time only Xenical (orlistat) is available to prescribe as a diet pill and only Appesat is offered as an appetite suppressant. We were slightly sceptical about Appesat if the truth be known but we decided to give some patients the option of trying it and it seems to have been a success, with a number of repeat orders coming through already and we have only been offering it for two weeks.

We have seen a report today from researchers at Liverpool University who have been studying Zotrim – a weight loss pill that is deemed to be herbal (although we dispute this definition as it actually contains quite a bit of caffeine as well as a few plant extracts). Anyway, people taking Zotrim apparently are able to lose 11 pounds in one month compared with 1 pound for people taking a placebo. Zotrim has been designed to make the user feel fuller for longer and it apparently delays the time that it takes the stomach to empty by 20 minutes. The researchers also suggested that those taking the diet pill had a reduced incidence of sugar cravings – a pitfall for many dieters.

Longer term studies have however been less complimentary. A study by Which?, the consumer affairs organisation, has suggested that while people lose weight in the short term on this slimming pill, they actually put it all back on again. Zotrim can be purchased in most chemist stores and supermarkets in the UK. The Online Clinic does not supply weight loss pills that have not been through rigorous clinical trials to demonstrate safety and effectiveness so Zotrim is not available through our website.

There’s already a fair amount of excitement about new diet pill Qnexa after clinical trials showed it could be a very effective aid to weight loss. However it has now been suggested that not only could it help users shed the pounds, but also bring relief to gritted-teeth partners by curing snoring.

A six-month study in the U.S which involved 45 snoring patients has indicated that the medication can combat the desperately irritating condition.

Not only is snoring frustrating for any bedfellows, it can also  increase the risks of high blood pressure and heart disease, which are associated with obstructive sleep apnoea – a condition that causes snoring.

Snoring is caused by a narrowing of the airways, which relax as someone falls asleep. Most people just carry on sleeping through this, but for those with sleep apnoea the airways totally collapse, shutting breathing off for at least 10 seconds. This leads sufferers to awake with a jolt and a snore, though most do not remember this as they immediately return to sleep.

The condition is strongly associated with weight problems, as excess fat around the neck increases pressure on the upper airways. Weight loss can significantly help the problem.

It is therefore still unclear whether the drug, made from a combination of low doses of phentermine and topiramate, an epilepsy medication, helps due to the patients' weight loss experience, or whether there is another action that improves sleep. More research would need to be carried out involving patients who are not overweight but do suffer from sleep apnoea.

It has not been a good few years for anti obesity drugs. Acomplia (Rimonabant) was withdrawn from the market in October 2008 and in January 2010 Reductil (Sibutramine) had its marketing authorization suspended across the whole of the EU following the publication of some data that suggested that the drug could increase the risk of non-fatal cardiovascular events in patients with a pre-existing heart condition.

Officials in New York have announced that they shut down 72 websites illegally selling prescription-only slimming pills.

In the international operation Pangea II, which saw Interpol, U.S agencies and task forces in 2 dozen countries work together, 751 websites were monitored and 72 were shut down. Officials investigated over 16,000 packages of potentially counterfeit medication, leading to a haul of almost 167,000 counterfeit and illegal pills. These included not only diet pills but antibiotics and steroids.

In total, 22 people have been taken into custody to be questioned over the findings of the operation.

There are believed to be many websites operating on the internet which claim to sell genuine Reductil, Xenical and herbal pills, which have actually been stolen or manufactured in illegal factories. Both Reductil and Xenical should only be sold with a legitimate doctor’s prescription.

The investigators said that many of the slimming pills seized where thought to be placebos or contain dangerous levels of the active ingredient used in the genuine forms of the medication. They also warned that counterfeit pills were often cut with dangerous other substances.

Interpol Secretary-General praised the operation, saying that officials have proved that the internet is not an ‘anonymous safe-haven’ for those using it for criminal purposes.

The pharmaceutical firm Vivus have announced that data on their new diet pills Qnexa will be released today at the annual meeting of the European Association for the Study of Diabetes, which will be taking place in Vienna in Austria.

Last month Vivus published very promising phase 3 data taken from their two-year clinical trial. The results showed that Qnexa promoted weight loss, as well as causing patients to experience improvements in their blood sugar, blood pressure and lipid levels.

While the medication is already in stage III trials as a diet pill, Vivus also hope to receive FDA approval to market it as a diabetes medication. Diabetes and obesity are very closely linked and medical experts have warned that as obesity increases worldwide, so too will the numbers of people developing type 2 diabetes.

The data Vivus plan to share with the conference is specific to the diet pill’s potential for combating diabetes. They have already announced that the medication significantly reduces patients haemoglobin, an indicator of blood sugar levels and it is already known that weight loss can improve people’s risk factors for the illness.

The president of Vivus, Leland Wilson, said in a press statement that he believed Qnexa had the potential to play an important role in the treatment of diabetes in the coming years.

The market share price of the pharmaceutical company Vivus has soared after the company published promising results from its late-stage clinical trial into the new diet pill Qnexa.

The medication is a combination of two drugs, the epilepsy medication called topiramate and the weight-loss drug phentermine. This was previously a popular diet pill but fell out of favour with doctors and specialists after effectiveness and safety concerns.

The Phase III trials showed that patients taking the medication lost a significant proportion of their body weight and also showed a reduction in their blood pressure, likelihood of developing type 2 diabetes and fat levels.

The trials were randomised. One involved 1,267 morbidly obese patients and the other involved 2,487 patients who were overweight or obese and had other health problems like diabetes or high blood pressure.

After a year of taking part in the trial, patients taking the medication at the highest dose lost 10.4% of their body weight on one trial and 11% on the other, compared with 1.6% to 1.8% amongst those taking the placebo. After taking into account the placebo effect this added up to weight loss of 9%, well surpassing the 5% the FDA demands for approval for a new diet pill to be approved.

Further FDA benchmarks were met when 70% of patients taking the drug lost at least 5% of their body weight, compared to 20% taking the placebo. The FDA say that at least twice as many patients taking a medication as those taking a placebo must lose at least 5%. However about 40% of those taking the high dose did not complete the year of treatment so this could be significant.

Vivus, based in California, say they plan to ask for FDA approval next year. We are not sure at this stage if the company is going to seek approval in the EU as phentermine has had a problematic history with the European Medicines Agency. 

A Scottish shipping firm has become the centre of an international investigation into the sales of diet pills.  The company they were working with is now being investigated by trading standards in the UK, as well as officials abroad.

Phytoscience, a pharmaceuticals distribution company, started working with Trading Planet Ltd in May. Since that time customers have been complaining in their hoards about an offer that seemed to promise a £1 trial of ‘Life Cleanse’ and ‘Acai Berry’ products. They failed to see in the small print that it contained a clause allowing Trading Planet to continue to send them further batches of the diet pills for £79 if they failed to cancel the agreement within 15 days.

Phytoscience said they have received many complaints from angry customers as their warehouse address was given as the return address. Their director, Chris Swainson, even said he had been sent rude letters to his home after furious consumers tracked him down.

He said that Trading Planet, who are believed to operate from Spain, are one of 12 clients. Phytoscience promised that if the deal was proved to be a scam they would ‘drop them like a hot potato’ but said that if they were working legally, they would continue to work with them.